Special Notice.pdf

SPECIAL NOTICE

INTENT TO SOLE SOURCE

This is a notification of an intent to award a contract to Cepheid, under NAICS code 325413 In-Vitro Diagnostic Substance

Manufacturing by Indian Health Services under the authority of FAR 6.302-1, Only One Responsible Source. This requirement is to secure molecular diagnostic reagent test kits and consumables compatible with the Cepheid GeneXpert Xpress platform.

Test kits include COVID-19 or Combination test kits used to test for COVID-19, Influenza A+B, and Respiratory Syncytial

Virus and sexually transmitted infections, and other clinically significant bacterial infection detections such as Methicillin-

Resistant S. aureus (MRSA) and C. difficile.

If you can provide the supplies requested, all responsible sources may submit a capability statement, which shall be considered by the Agency and may be e-mailed to Ashley.Velasquez@ihs.gov referencing notice number PHX-SS-23-002 by 8 AM PDT, October 27, 2022. A determination by the Government not to compete this proposed contract acquisition based upon responses to the notice is solely within the discretion of the Government. Information received will normally be considered solely for the purpose of determining whether to conduct a competitive procurement. This notice does not obligate the Government to award a contract or otherwise pay for information provided in response. The Government reserves the right to use information provided by respondents for any purpose deemed necessary and legally appropriate. Any organization responding to this notice should ensure that its response is complete and sufficiently detailed. Information provided will be used to assess tradeoffs and alternatives available for the potential requirement and may lead to the development of a solicitation.

Respondents are advised that the Government is under no obligation to acknowledge receipt of the information received or provide feedback to respondents with respect to any information submitted.

Any solicitation resulting from the analysis of information obtained will be announced to the public in Federal Business

Opportunities in accordance with the FAR Part 5. However, responses to this notice will not be considered adequate responses to a solicitation. No proprietary, classified, confidential, or sensitive information should be included in your response. The Government reserves the right to use any non-proprietary technical information in any resultant solicitation(s).

Phoenix Area IHS – BPA Estimated Supplies Base Year

Phoenix

Indian Med Ctr

Whiteriver Hospital

Hopi Health Care Ctr

Parker Hospital

Peach Springs

Health Ctr

Fort Duchesne Health Ctr

Fort Yuma Health Ctr

Supply Description Catalog Number Estimated Qty

Estimated Qty

Estimated Qty

Estimated Qty

Estimated Qty

Estimated Qty

Estimated Qty

KIT,CARBA-R,IVD,GX BXCARBAR-10

KIT,CDIFF/EPI,GX,IVD,10-TEST BXCDIFF/EPI-10

KIT,CDIFF,10-TESTS,GX,IVD GXCDIFFICILE-

10-TESTS,GX,IVD

13 6 8

KIT,CT/NG,GX,IVD GXCT/NG-10

840 343 119 36 21 35

KIT,EV,10-TESTS,GX,IVD GXEV-100N-10

KIT,FII/FV,10-TESTS,GX,IVD GXFIIFV-10

KIT,GBS 10-TESTS,GX,IVD GXGBS-100N-10

7 6

KIT,GBS LB,10-TESTS,GX,IVD GXGBS-LB-10

42 21

KIT,MRSA,10-TESTS,GX,IVD GXMRSA-100N-

KIT,10-TEST,MRSA NXG,IVD,GX GXMRSA-NXG-

KIT,MRSA,10-TESTS,GX,IVD GXMRSA-100N-

KIT,MRSA/SA SSTI,10-

TESTS,GX,IVD

GXMRSA/SA-

SSTI-10

70 8 21 28 18 5

KIT,MTB,IVD,US GXMTB/RIF-US-

KIT,SA COMP,10-TESTS,GX,IVD GXSACOMP-10

9 35 5

Phoenix

Indian Med Ctr

Whiteriver Hospital

Hopi Health Care Ctr

Parker Hospital

Peach Springs

Health Ctr

Fort Duchesne Health Ctr

Fort Yuma Health Ctr

Supply Description Catalog Number Estimated Qty

Estimated Qty

Estimated Qty

Estimated Qty

Estimated Qty

Estimated Qty

Estimated Qty

KIT,XPERT TV_US,10-TEST GXTV-10

147 9

KIT,XPRESS,COV-2/FLU/RSV

PLUS,10 TEST

XP3COV2/FLU/RSV-

2800 1400 448 540 420 182 119

KIT,XPRESS,SARS-COV-2

PLUS,10-TEST

XP3SARS-COV2-10 350 315 182 91 45 70 45

KIT,XPRESS,FLU,US-IVD,10 TEST XPRSFLU-10

KIT,XPRESS,FLU/RSV,US-IVD,10

TEST

XPRSFLU/RSV-10 5

KIT,XPRESS,STREPA,US-IVD,10

TEST

XPRSTREPA-10 406 50

ESW AB,LIQUID AMIES,

FLOCKED,COPAN,480CFA

480CFA 6 6

CEPHEID COLLECTION DEVICE 900-0370

12 4 4 11 4 4

BUNDLE,OEM CONTROL

REAGENTS,MRSA/SA

MRSA/SA-BU1 4

A CASE OF CEPHEID

COLLECTION DEVICE

SWAB-500 12

NP swab collection kit for Xpert Flu, Xpert FLU/RSV, Xpert Xpress FLU/RSV

SWAB/B-100 44 23 19 11 4 5

NASAL SWAB AND TRANSPORT

MEDIUM, 100/KIT

SWAB/F-100 232 126 118 88 18 5 6

COLLECTION KIT, XPERT

SWAB,US CE IVD,50

SWAB/G-50 2100 24 13 4 4

CollectionKitA urine URINE/A-50

525 54 21 8 6 8

TEST KIT DESCRIPTION:

Critical Infectious Diseases

• Xpert® EV - Fast molecular in vitro diagnostic enteroviral meningitis test

• Xpert MTB/RIF - Accurate detection of MTB and Rifampin resistance mutations

• Xpert Xpress Flu^ - Accurate and reliable detection of Flu A and Flu B, in as soon as 20 minutes#

• Xpert Xpress Flu/RSV^ - Accurate and reliable detection of Flu A, Flu B, or RSV in as soon as 20 minutes†

• Xpert Xpress SARS-CoV-2‡ - A rapid, near-patient test for the detection of the 2019 novel coronavirus that causes COVID-19#

• Xpert Xpress CoV-2/Flu/RSV plus‡- Actionable, rapid respiratory results to meet the challenges of the ongoing pandemic**

• Xpert Xpress Strep A^ - Qualitative real-time PCR test providing accurate detection of Group A Streptococcus in as soon as 18 minutes# Oncology & Genetics

• Xpert BCR-ABL Ultra - Sensitive and quantitative monitoring of BCR-ABL mRNA in patients with chronic myelogenous leukemia (CML)

• Xpert BCR-ABL Ultra p190^^ (RUO) - Quantitative assay for the BCR-ABL minor breakpoint (p190) transcript

• Xpert FII & FV - 30-minute test for genetic risk of thrombosis Women's & Sexual Health

• Xpert TV - Fast and accurate diagnosis of trichomoniasis for both women and men in about 40 minutes#

• Xpert CT/NG - 90-minute detection and differentiation of Chlamydia trachomatis (CT) and Neisseria gonorrhoeae (NG)

• Xpert GBS - For direct intrapartum screening in labor/delivery

• Xpert GBS LB - For antepartum screening Healthcare-Associated Infections

• Xpert C. difficile - Detection of Clostridium difficile in as soon as 40 minutes#

• Xpert C. difficile/Epi - 45-minute detection & differentiation of Clostridium difficile and the Epidemic 027 strain

• Xpert Carba-R - qualitative, on-demand, real-time PCR test for the detection and differentiation of KPC, NDM, VIM, OXA-48, and IMP in 48 minutes

• Xpert MRSA NxG - Accurate, fast, on-demand PCR test that detects Methicillin-resistant Staphylococcus aureus (MRSA) directly from nasal swabs

• Xpert MRSA/SA Blood Culture - Accurate detection of Staphylococcus aureus (SA) and MRSA in positive blood culture specimens in about an hour

• Xpert MRSA/SA SSTI – Detection of MRSA & SA skin and soft tissue infections in about one hour

• Xpert Norovirus - Rapid identification and differentiation of Norovirus GI and GII in less than one hour

• Xpert SA Nasal Complete - presurgical testing of S. aureus and MRSA in about an hour

• Xpert vanA - The first rapid and accurate test to assist with VRE surveillance